Anastomosis device and related methods

ABSTRACT

Described are methods and devices relating to reconnecting tissue of the urethra, e.g., connecting the urethra and bladder after a radical prostatectomy, wherein the devices incorporate tissue approximating structure such as tines to maintain contact between severed tissue, such as a severed bladder neck tissue and a severed urethral stump tissue, preferably without the use of sutures.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present non-provisional Application claims the benefit of commonlyassigned provisional Application having Serial No. 60/405,140, filed onAug. 22, 2002, and entitled SURGICAL STENT DEVICES AND METHODS, whichApplication is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

The present invention generally relates to methods of reconnectingurethra and bladder tissues after a radical prostatectomy, and relateddevices. Particular embodiments of the invention relate to methods anddevices for performing a vesico-rethral anastomosis.

BACKGROUND

In a radical prostatectomy, the surgeon removes all or most of thepatient's prostate. Because the urethra travels through the prostateimmediately before reaching the bladder, the upper part of the urethrais removed in the surgery. The procedure leaves a severed urethral stumpand a severed bladder neck. To restore proper urinary functions, thebladder and the urethra must be reconnected.

Conventionally, a surgeon may execute delicate suturing operations withtiny, fine needles to reconnect these anatomical bodies. Installation ofsutures, however, with a needle, to connect the severed tissues, can bea difficult and often technique-sensitive task. Many factors can makethis task difficult, including a very small amount of tissue to workwith (at the urethral stump and at the bladder neck), proximal uretersat the bladder, and a proximal nerve bundle and sphincter at theurethral stump. All of these add up to a complicated and delicatesuturing procedure that, if not performed properly, could result incomplications such as leakage, difficulty in healing or failure to heal,incontinence, or impotence. Specific problems include necrosis of thesutured tissues; stricture of the urethra, which impedes the flow offluid through it; and a urethra-bladder connection that is notfluid-tight. In addition, methods of suturing the urethra to the bladderallow for accidental or inadvertent piercing of the nearby neurovascularbundle, which can cause incontinence or impotence.

SUMMARY

The invention relates to an anastomosis device that includes a catheterbody and tissue approximating structure. The tissue approximatingstructure can be used to cause or maintain contact between severedportions of tissue to allow or cause the severed tissue surfaces to healtogether, instead of using sutures. The device may be used, for example,in performing procedures such as a vesico-urethral anastomosis inassociation with a radical prostatectomy, or with an end-to-end urethralanastomosis. Advantageously, the device, including the tissueapproximating structure, can be left installed during the healingprocess to function to allow the tissue to heal while at the same timefunctioning to drain urine from the bladder.

Preferred tissue approximating structure may be remotely actuatable froma retracted position (e.g., within the device) to a position of use,external to the device. As an advantage, embodiments of the tissueapproximating structure can be moved and adjusted remotely (e.g., usinga an actuating mechanism at the proximal end of the device) during asurgical procedure. The device, overall, thus allows a surgeon toposition and re-position a tissue approximating structure during aprocedure to effect optimal positioning of the tissue approximatingstructure and of the tissue.

Embodiments of anastomosis devices of the invention, in addition to thetissue approximating structure, can include features and structures thatfunction to drain the bladder, e.g., through a drain lumen, while at thesame time functioning as a tissue approximating structure that causescontact between severed tissue to allow the severed tissues to healtogether. Methods of the invention can use such an anastomosis device,including both a draining function and a tissue approximating function,to accomplish healing of the anastomosis, without sutures, and drainingof the bladder, with the single anastomosis device and preferablywithout removing or replacing the device during or after the procedureuntil healing is complete. The anastomosis device can be installedduring or after a radical prostate removal procedure, and can remaininstalled with the bladder-draining function and thetissue-approximating function in effect until the anastomosis iscompletely healed and the severed tissue, e.g., bladder and urethra, arere-connected. Thus, an advantage associated with inventive methods anddevices can be that the anastomosis device performs dual functions wheninstalled during and following an anastomosis procedure, of draining thebladder and functioning as a tissue approximating structure, at the sametime.

Also advantageously, inventive methods and devices avoid the need to usesutures to connect severed tissue such as a bladder neck and urethralstump. The ability to avoid sutures provides very significant advantagesof avoiding the potential for damage to surrounding tissues and nervesthat can be caused by installation of sutures using a needle. Suchdamage can include, for example, damage to ureters at the bladder ordamage to the sphincter or nerves located in the perineal floor. Damageto any of these tissues has the potential to cause incontinence orimpotency. Additionally, installing sutures is a difficult andtechnique-sensitive process that must be performed in a confined spaceand that would be avoided if possible based on other alternatives. Thus,the invention offers the very significant advantage of eliminating theneed to use sutures to re-attach severed tissues, and the attendantpotential damage to those sensitive proximal tissues and nerves and thepossibility of incontinence or impotency.

In another respect, the inventive methods and devices, by eliminatingsutures, can significantly reduce the amount of time required to performan anastomosis procedure. For example, the amount of time for sutureinstallation can be in the range of from 20 to 30 minutes up to an hour,depending on the type of procedure. A suturing step of a retropubicprocedure, for example, may take 20 or 30 minutes, or up to an hour fora laparoscopic procedure. This amount of time may be significantlyreduced, according to the invention, due to the elimination of asuturing step. Reduced procedure time creates the attendant advantagesof reduced patient time under anesthesia, which can reduce the costs andcomplications caused by anesthesia, as well as related general costs.

According to the present description, the term “distal end” refers to aportion of an anastomosis device that is inserted into a body during ananastomosis procedure and that then becomes located in the region of thebladder, urethra, urethral stump, and perineal wall. The term “proximalend” refers to a portion of an anastomosis device that is opposite fromthe distal end, including a portion that remains exterior to the bodyduring use.

The terms “tissue approximating” and simply “approximating” refer to aprocess of bringing or holding body tissues in contact for healing.Examples include: the process of bringing severed surfaces of a bladderneck and a urethral stump, or two opposing severed urethral tissues,into contact for healing; and the process of holding severed surfaces ofa bladder neck and a urethral stump, or two opposing severed urethraltissues, together for healing.

An aspect of the device relates to an anastomosis device comprising ahollow, elongate, flexible catheter body having a proximal end and adistal end; an inflatable balloon at the distal end; a drainage lumenconnected to the distal end; and tissue approximating structure on thecatheter body on a proximal side of the balloon at a location to contactsevered tissue during an anastomosis procedure.

Another aspect of the invention relates to an anastomosis devicecomprising a hollow elongate flexible catheter body having a proximalend and a distal end; an inflatable balloon at the distal end andinflation means for inflating the balloon; drainage means connected tothe distal end for draining urine from a bladder; and tissueapproximating means on the catheter body on the proximal side of theballoon for holding severed tissue in contact for healing.

Another aspect of the invention relates to a method of performingurethral anastomosis. The method comprises inserting a portion of ananastomosis device into the urethra, the anastomosis device comprisingtissue approximating structure and a distal end comprising a balloon;inflating the balloon in the bladder; and using the tissue approximatingstructure to hold severed tissue together. Preferably, the devicefurther comprises drainage apertures for draining a bladder and themethod comprises draining a bladder.

Yet another aspect of the invention relates to a method of performing aurethral anastomosis. The method comprises severing a urethra to leaveopposing severed urethral tissues; inserting a distal end of ananastomosis device through the urethra and into the bladder, theanastomosis device comprising tissue approximating structure and aballoon; inflating the balloon inside of the bladder, and holding theopposing severed urethral tissues together in healing contact using thetissue approximating structure. Preferably, the device further comprisesdrainage apertures for draining a bladder and the method comprisesdraining a bladder.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view to illustrate general aspects of radicalprostate removal.

FIGS. 2 and 2 a schematically illustrate an embodiment of anastomosisdevices according to the invention.

FIGS. 3 and 3 a schematically illustrate an embodiment of anastomosisdevices according to the invention.

FIGS. 4 and 4 a schematically illustrate an embodiment of anastomosisdevices according to the invention.

FIGS. 5 and 5 a schematically illustrate an embodiment of anastomosisdevices according to the invention.

FIGS. 6 and 6 a schematically illustrate an embodiment of anastomosisdevices according to the invention.

FIG. 7 schematically illustrates an embodiment of anastomosis devicesaccording to the invention.

FIG. 8 schematically illustrates an embodiment of an anastomosis deviceof the invention.

FIGS. 9, 9 a, 9 b, and 9 c schematically illustrate an embodiment of ananastomosis device and a method of the invention. FIGS. 9 b and 9 c areclose-up schematic illustrations of portions of FIGS. 9 and 9 a,respectively.

All drawings are not to scale.

DETAILED DESCRIPTION

An anastomosis device useful according to the invention can be anyanastomosis device that can be useful in the practice of an anastomosismethod described herein, e.g., an anastomosis method associated with aradical prostatectomy. An example of a useful design, generally, is thetype sometimes referred to as a Foley catheter that has been constructedto include modified features as also presented in the presentdescription including tissue approximating structure.

An anastomosis device of the invention typically includes a hollow,elongate, flexible catheter body having a proximal end and a distal end.An inflatable balloon can be located near the distal end, and aninflation lumen for inflating the balloon can extend to the balloonalong the catheter body, e.g., along a portion or all of the catheterbody from the proximal end to the balloon. During use, the balloon canrest against the neck of the bladder to prevent urine from entering theneck and to prevent urine from contacting the anastomosis site. Urine atthe anastomosis site has the potential to cause difficulties in healingor to cause a stricture, among other deleterious effects. With theballoon blocking the bladder neck during use, urine will pool in thebladder and can be drained from the bladder, for example, using one ormore draining apertures at the distal end of the anastomosis deviceconnected to a drainage lumen. A drainage lumen can extend from one ormore drainage apertures near the distal end, e.g., from apertures at thedistal end to a location that is at or near the proximal end. As aparticular example, a port may be present at the proximal end to connectthe drainage lumen to a urine collection device.

Overall, an anastomosis device can contain various lumens (e.g., forinflating a balloon, for drainage, for containing actuating mechanismsfor tissue approximating structure, etc.) and actuating mechanismsrunning along at least a partial length of a catheter body. Themechanisms and lumens can be arranged in any useful configuration suchas coaxially, side-by-side, or according to any other usefulconfiguration. A lumen or a mechanism (e.g., actuating mechanism) thatruns along at least a portion of the length of the catheter body may bediverted at the proximal end of the catheter body to a port thatprovides access to the lumen or mechanism during use, as is known.

According to the invention, the anastomosis device includes tissueapproximating structure that can be used to place or hold a cut orsevered tissue or tissue surface in place for healing while the catheteris installed. Referring to FIG. 1, a radical prostatectomy procedureincludes removal of the prostate 10 (indicated in dashes) and urethra 8(also in dashes), leaving bladder 2 with bladder neck 4 having a severedtissue surface 6 at one end of removed urethra 8, and a urethral stump12 extending from perineal floor 14, with urethral stump 12 havingsevered tissue surface 16 opposing the severed surface 6 of bladder neck4. Referring to FIG. 9, an end-to-end urethral anastomosis procedureincludes a step of severing the urethra 8, below perineal wall 14, toleave two opposing severed urethral tissues 8 a and 8 b. While thefollowing description presents inventive devices and methods primarilyin the context of vesico-urethral anastomosis relating to radicalprostatectomy, it will be apparent, and is also described, that theinvention can be applied to a variety of other procedures that benefitfrom tissue approximating structures and in particular where a fluidflow is also desired, such as drainage of urine. A specific example isan end-to-end urethral anastomosis procedure.

A tissue approximating structure according to the invention can be astructure of the device that can be used to cause contact betweensevered tissues, such as severed urethral tissues, or such as severedtissue of the bladder or bladder neck with severed tissue of theurethral stump or perineal floor, or alternatively or additionally tohold severed tissue surfaces in contact with each other for healing. Thetissue approximating structure may include, for example, one or multipleballoon or balloon-like structures that can be placed against the insideof the bladder or underneath the perineal floor to bring the severedbladder neck tissue into contact with the severed tissue surface of theurethral stump. Alternately, the tissue approximating structure mayinclude elongate structures such as a needle, tine, prod, probe, or thelike, which may have a blunt or a sharp end and may movably extend orprotrude from an aperture in a flexible catheter body at a locationwhere the structure can function as an approximating structure, e.g., atthe distal end of the device where the structure will be near thebladder or perineal wall (when installed), or at a severed urethra belowthe perineal floor (when installed). Combinations of balloons andelongate structures may also be useful in certain applications. Thetissue approximating structure does not require and can preferablyexclude sutures and any component or structure designed to function incombination with a suture or suturing device such as a needle.

An example of a useful tissue approximating structure can be in the formof a sharp or blunt elongate structure (e.g., a sharp-ended needle ortine) that can be movably extended from an aperture at a distal end of,or at a length of, a catheter body, to thereby contact and optionallypenetrate into or through one or more of a tissue of the bladder,bladder neck, urethra, bulbar urethra, urethral stump, or perinealfloor, to place opposing severed tissue surface into contact forhealing, and preferably also to hold the tissues in contact with eachother during the healing period. Certain embodiments of the inventioncan include sharp or blunt elongate tissue approximating structure(e.g., a sharp-ended needle or tine) that can be movably extended froman aperture at a distal end of a catheter body to place opposing severedtissue of the bladder neck into contact with a severed tissue surface ofthe urethral stump, or vice versa, and preferably also to hold thetissues in contact with each other during the healing period.

Advantageously, in one embodiment, a tissue approximating structure mayinclude one or more sharp elongate, straight or curved, fine metal tinesthat movably extend from the distal end of the catheter body at alocation to allow contact and optionally penetration of the urethralstump proximal tissue in the adjacent perineal floor, urethra, or bulbarurethra. In this form, in addition to causing contact between thesevered tissue surfaces of the urethral stump and the bladder neck,preferred elongate tissue approximating structure may also accomplishthe desirable effect of re-exposing the urethral stump from the perinealfloor by pressuring the urethral stump from below. As is common withvesico-urethral anastomosis procedures that include sutures, re-exposingthe urethral stump after the urethra is severed can be useful because ofthe often very small amount of tissue associated with the urethralstump, and because of the tendency of the urethral stump to draw intothe perineal floor.

As mentioned, certain preferred embodiments of tissue approximatingstructures can be movable, e.g., from a retracted or withdrawn positioninside of the catheter body (e.g., for tines or needles) or anon-inflated position (for a balloon), to an employed or extended orotherwise “non-retracted” position. In the employed position, whereinthe tissue approximating structure extends beyond the dimension(diameter) of the catheter body, e.g., as with a tine extending throughan aperture in the catheter body wall, the tissue approximatingstructure can be positioned to contact a tissue and facilitate healingbetween a severed tissue and another severed tissue.

In general, a tissue approximating structure can include any structurethat can be incorporated into or along the catheter body and can bemanipulated, e.g., using a mechanism extending along the catheter body,to place or hold severed tissues in contact for healing. An anastomosisdevice according to the invention can have one or multiple tissueapproximating structures, optionally multiple structures positioned atdifferent distances along the length of the catheter body at one or morelocations that allow the tissue approximating structures to contact andplace pressure on opposing severed tissue surfaces when the anastomosisdevice is installed during an anastomosis procedure and afterward, forhealing. For placing and holding severed bladder and urethral stumptissues, tissue approximating structure can be located at a suitablelength along the catheter body, such as at the distal end where thetissue approximating structure will contact those tissues wheninstalled. For placing and holding severed urethra tissue below theperineal wall, tissue approximating structure can be located furtherfrom the end of the device, at a suitable length along the catheter bodyto contact urethral tissue below the perineal wall when installed.

Exemplary tissue approximating structure may be in the form of a rigidelongate structure that moves from a retracted position (e.g., inside ofthe catheter body) to an extended position through apertures in thecatheter body, such as a movable, elongate, tine or needle typestructure. Such a tine or needle structure may include a pointed end topenetrate into or through a tissue. Exemplary elongate structures can bepositioned to movably engage apertures in the catheter wall throughwhich the elongate structures can be extended or retracted. Optionally,a guide such as a metal, ceramic, rigid plastic, or polymeric guide canbe placed at the aperture between the catheter body wall and the movableelongate structure.

Alternatively, the tissue approximating structure may include one or twoballoons that can be positioned to cause contact of two opposing severedtissue surfaces. For example, two balloons may be located to contact theopposite sides of a bladder wall and a perineal floor, one balloon inthe bladder and the other below the perineal floor, at a spacing thatmaintains contact between a severed bladder neck tissue and a severedurethral stump.

In certain preferred embodiments, a tissue approximating structure maycomprise multiple, (optionally) opposing sets of elongated structuressuch as rigid or semi-rigid tines, needles, or the like, which may bestraight or curved, and which may optionally include a sharp pointed tipto penetrate into or through a bladder neck, bladder wall, perinealfloor, urethra tissue, bulbar urethra, urethral stump, or any othertissue that can be brought into contact or held together by devices ormethods described herein. For example, one or a set of tines may belocated at positions along the catheter body where tissue approximatingstructure can be used to contact severed tissue or tissue proximal tosevered tissue, to bring together and hold in place severed tissue forhealing with a corresponding severed tissue. As one specific example, ananastomosis device according to the invention may include multiple setsof elongate tissue approximating structures including a first set ofmovable distal tissue approximating structures positioned to extendthrough apertures in the hollow catheter body, the distal tissueapproximating structure located on the proximal side of the balloon, anda second set of movable proximal tissue approximating structurepositioned to extend through apertures in the hollow catheter body, theproximal tissue approximating structure located on the proximal side ofthe movable distal tissue approximating structure. Each tine or set oftines can be extended independently and remotely, for example byoperation of an actuating mechanism such as connected wire or shaft thatruns through or along the length of the catheter body.

According to certain presently preferred embodiments of the invention, atissue approximating structure may comprise a balloon located at thedistal end of the device, the balloon being positioned inside of thebladder during use. FIGS. 2 and 2 a illustrate such an embodiment of ananastomosis device of the invention, installed for use within urethra 8and bladder 34 following removal of a prostate (not shown).

Referring to FIG. 2, a prostate has been removed to leave a severedurethral stump tissue 22 and opposing severed bladder neck 24.Anastomosis device 20 is installed through urethral stump 22 and bladderneck 24. The device 20 comprises a catheter body 21 and balloon 26located at the distal end 28 of the device. Preferably and as shown, thedevice also includes drain lumen 23 and drain apertures 29 locatedbetween the tip 19 of the distal end of the device 20 and balloon 26.Balloon 26 is inflated, after insertion into the bladder 34, by a flowof fluid through balloon lumen 30. Pressure (e.g., traction as shown byarrow 31) can then be applied through the length of device 20 to producea pressure against the inside of bladder 34 from inflated balloon 26.Referring to FIG. 2 a, balloon 26 can be brought to place pressure onthe interior of the bladder 34 and draw the severed bladder neck tissue25 into contact with severed urethral stump tissue 27. The surface ofsevered bladder neck tissue 25 aligns automatically with the surface 27of severed urethral stump 22, around and along the axis of the catheterbody 21, provided that no gap exists between the surfaces 25 and 27 ofthe respective severed tissues.

In related embodiments of devices according to FIGS. 2 and 2 a, theanastomosis device 20, which in FIGS. 2 and 2 a uses balloon 26 as atissue approximating structure, may optionally and preferably includeadditional components or features as part of the tissue approximatingstructure. As an example, FIG. 3 shows how additional tissueapproximating structure may be located along the length of the catheterbody 21, at a location that will place the structure at or below theurethral stump 22 or the perineal floor 31. Such additional tissueapproximating structures may be in the form of one or preferablymultiple elongate metal tines 33 (three are shown, in the retroactedposition) having sharp ends to penetrate into the urethral stump,perineal wall bladder tissue urethral tissue, or other location that isuseful to draw or hold together severed tissue. Located to exit thecatheter body 21 through apertures (not shown) to contact tissue at orproximal to the urethral stump 22 or perineal floor 31, the tines 33 mayextend from the catheter body 21 at a position (when installed, with thebladder drawn down to the perineal floor) below or proximal to theurethral stump 22 or perineal floor. By extending from an aperture atthat location, the tines (or another form of tissue approximatingstructure) may produce pressure against the urethral stump 22 in adirection that pushes the urethral stump toward bladder neck 24.

Referring still to FIG. 3, the prostate (not shown) has been removed toleave a severed urethral stump tissue 22 and opposing severed bladderneck 24. Anastomosis device 20 is installed through urethra 8, urethralstump 22, and bladder neck 24. The device 20 comprises balloon 26located at the distal end 28 of the device. Preferably and as shown, thedevice also includes drain lumen 23 and drain apertures 29. Balloon 26is inflated and pressure (e.g., traction 31) is applied through thelength of device 20 to produce a pressure against the inside of bladder34 (see FIG. 3 a) from inflated balloon 26 to place the severed bladderneck tissue 25 in contact with severed urethral stump tissue 27. Asshown in FIG. 3 a, the surface 25 of the severed bladder neck alignsautomatically with the surface 27 of the severed urethral stump, aroundand along the axis of the catheter body 21. Also shown in FIG. 3 a aretines 33 that extend from catheter body 21 at a position below perinealfloor 35 and penetrate into perineal floor 35 (optionally contacting orpenetrating tissue below the perineal floor 35 such as the bulbarurethra, which is not shown, or urethra 8). The severed urethral stumptissue 27 is pushed against the severed surface 25 of the bladder neckto allow healing together and reconnection of the two severed tissuesurfaces.

FIG. 4 shows another example of a distal end of an approximating deviceof the invention. Distal end 40 includes a catheter body 42 with aproximal end 44 (not shown). The device includes a balloon 48, aninflation lumen 50 (partially shown), and a drainage lumen 52 (partiallyshown). Inflation lumen 50 extends within the catheter body 42 from theproximal end to the balloon 48, in fluid communication with the balloon48, for inflating and deflating the balloon 48. The drainage lumen 52extends from the proximal end 44 to the distal end 40 and to drainageapertures 46. One set of tines 54 is located on the distal end 40 of thedevice, retractably extending through catheter body 42, proximal toballoon 48. Tines 54 movably extend through apertures (not numbered) andin the general direction back toward the proximal end of the catheterbody and away from the distal end. Another set of tines 56 is located atthe distal end 40 of the device 40, but toward the proximal end of thedevice relative to balloon 48 and also toward the proximal end of thedevice relative to tines 54. Tines 56 movably extend through apertures(not numbered) and in the direction toward the distal end of thecatheter body and away from the proximal end. Each set of tines 54 and56 can be independently remotely operated, e.g., by using actuatingconnections 55 and 57 that extend through the catheter body 42 to theproximal end.

In use, when anastomosis device 40 of FIG. 4 is installed, balloon 48 islocated inside of the bladder and tines 54 can be positioned at aposition along the catheter body 42 so that when extended from the body42, tines 54 penetrate into tissue for placing and preferably holding asevered tissue in place next to a corresponding severed tissue. As aspecific example, tines 54 and 56 can be positioned along the catheterbody 42 so that when extended from the body 42 during use, tines 54penetrate into tissue of the bladder and tines 56 penetrate into tissueof the perineal floor, the opposing tines applying pressure to hold thesevered urethral stump against the bladder neck.

Still another embodiment of an anastomosis device of the invention canhave a single set of elongate tissue approximating structures, e.g.,curved tines, that extend from a single position (i.e., a commondistance from an end) along the length of a catheter body. The tissueapproximating structure may extend through apertures and from thecatheter body to contact a tissue, e.g., penetrating into the tissue andoptionally through the tissue. An example is shown in FIG. 5. FIG. 5illustrates a distal end 60 of an exemplary anastomosis device of theinvention, containing a single set of three curved tines 62. In use,when the anastomosis device having distal end 60 is installed, balloon68 is located inside of a bladder and tines 62 can, for example, bepositioned at a position along the catheter body 64 to extend from thecatheter body 64 to penetrate first into and through tissue of theperineal floor, then into the bladder wall (see figure Sa). As a result,the single set of tines 62 can be effective to hold a severed bladdertissue in place next to a severed urethral stump. Tines 62 can beextended or retracted through apertures 66 in catheter body 64, usingactuator 61. In this embodiment, the actuator 61 runs through a lumenalong the length of catheter body 64 and splits into or connects to thethree individual tines 62, which exit the catheter body 64 throughapertures 66.

An alternative embodiment of anastomosis device could include a singleset of tines that extend from the anastomosis device in the oppositedirection from that shown in FIG. 5. Such an embodiment is shown in FIG.6. FIG. 6 illustrates an example of a distal end 70 of an anastomosisdevice according to the invention, containing a single set of curvedtines 72. In use, balloon 78 is located inside of a bladder, and tines72 can be positioned, for example, along the catheter body 74 to extendfrom the catheter body 74 to penetrate first into and through tissue ofthe bladder, then into and through the perineal floor (see FIG. 6 a).Tines 72 can be extended or retracted through apertures 76 in catheterbody 74 using actuator 71. In this embodiment, the actuator 71 runsthrough a lumen along the length of catheter body 74 and splits into orconnects to the three individual tines, which exit catheter body 74through apertures 76.

Alternate embodiments of anastomosis devices (and related methods) willbe useful according to this description, as will be appreciated by thoseof skill, even if not specifically illustrated or described. Forexample, combinations of the above described features of an anastomosisdevice, as well as other features such as additional or differentstructures or protrusions, can be useful to function as tissueapproximating structures. Examples may include a second balloon (see,e.g., FIG. 7) or other movable, inflatable, or stationary structures.Additionally, the number or structure of the tissue approximatingstructure (e.g., tines) may be of any useful variation, as may be themechanism by which a tissue approximating structure is actuated.

The catheter and its componentry may be made of materials normally usedand known to be useful for such devices, or future developed materials,especially including known or future developed materials that arerelatively inert and biocompatible. For example, a catheter body may beprepared from a flexible plastic or polymeric material. Examples ofpresently understood materials that may be useful for a catheter bodycan include silicones, latex, rubbers, polyurethanes, and combinationsof these or other materials. A tissue approximating structure can bemade from these or other materials, including relatively rigid plastics,polymers, or metals, optionally including bioresorbable materials suchas bioresorbable polymers. Examples of metals include stainless steel,nitinol, titanium, tantalum, as well as alloys or combinations of thesematerials.

Optionally, portions or all of an elongate tissue approximatingstructure may be bioresorbable, if desired. This could allow for devicesand methods that allow the bioresorbable structure (e.g., abioresorbable tine) to remain in place after removal of the anastomosisdevice, after which the bioresorbable structure would resorb over time.

The tissue approximating structure can be actuated by any useful methodor device or structure, for example as illustrated in the attachedfigures, by an elongate actuator mechanism extending through a lumen ina catheter body. The actuator mechanism may be of the same material asthe tissue approximating structure, or may be a different materialsecured to the tissue approximating structure. The actuator may extendout of the proximal end of a device or may enter the device through alateral port located at the proximal end of the device.

The device, in addition to the foregoing, may also include othermechanisms or features, as will be appreciated by those of skill.Examples include features such as a temperature probe or temperaturereading mechanism. As one example of a specific feature that may beincorporated into a preferred embodiment of the invention, an actuatormechanism for a tissue approximating structure may be removable at anexterior portion of the device. For example, an actuator mechanism mayextend through a catheter body through an end or through a port at theproximal end of the device. The actuator mechanism or a portion thereofmay be removably attached to the device and the tissue approximatingstructure, so that the surgeon can operate the tissue approximatingstructure while the actuator mechanism is attached during a surgicalprocedure, and the actuator may be removed following the procedure toavoid inadvertent actuation by the patient during the healing period,during which the device is still installed in the patient. When the timecomes to remove the device, the actuator mechanism may be re-attachedexternally to uninstall the device.

In general, a catheter can be used during urethral anastomosisprocedures such as that associated with a radical prostatectomy, e.g.,vesico-urethral anastomosis, with the catheter functioning to removeurine from the bladder after the procedure. By ordinary methods, andaccording to the inventive methods described herein, an anastomosisdevice can be used by inserting the elongate flexible catheter bodythrough the urethra and into the bladder. A portion of the distal end ofthe device becomes located inside of the bladder where the balloon canbe inflated and where the drainage lumen can be used to drain thebladder and keep urine out of the bladder during and subsequent to theprocedure. The bladder can preferably be drained of urine during theprocedure and during the healing period following the procedure, becauseurine is preferably kept away from the site of anastomosis to facilitatehealing, and also to prevent urine from creating pressure within thebladder.

A typical Foley catheter can include a drainage lumen and an inflationlumen for inflating and deflating the balloon. The balloon is normallydeflated until properly positioned in a patient's bladder. Once thecatheter is properly positioned, the inflation lumen delivers fluid toinflate the balloon. The inflated balloon can be used to hold thecatheter in place, and, in embodiments of the invention, can also beused to draw the bladder and bladder neck toward the urethral stump andto hold the bladder in that position during healing of the bladder neckto urethral stump. Inventive devices and methods additionally allow forthe use of other tissue approximating structures, such as tines,needles, probes, prods, balloons, etc., or combinations of these andother structures, to place severed tissue into contact and hold thetissues together for healing.

FIG. 8 shows a single example of a modified-Foley-catheter-typeanastomosis device according to the invention. Device 100 includesdistal end 108, catheter body 102, balloon 104, and drainage aperture106. Tissue approximating structure can be located along the catheterbody 102, for example, as illustrated, along catheter body 102approximately midway between the far ends of the device. (This locationmay be useful, for example, in performing an end-to-end urethralanastomosis procedure; a location closer to balloon 104 may be usefulfor a vesico-urethral anastomosis). Tissue approximating structure ofdevice 100 is shown as a single set of tines 122 (shown in an extendedposition) but may alternatively include an additional set of (optionallyopposing) tines, a different type of elongate structure such as a probeor prod or needle, a balloon, or any other structure that may be used toplace or hold severed tissue in contact with another opposing severedtissue for healing.

Still referring to FIG. 8, device 100 includes proximal end 110 thatincludes a port 114 and that can be connected to attachment 112. Usefulsuch proximal end and attachment configurations are well known, and suchknown or future developed proximal ends and attachments will beunderstood to be useful according to devices and methods of theinvention. In the illustrated embodiment, proximal end 110 includes aport 114 that may connect to a lumen (not shown) such as an inflationlumen for balloon 104 or a drainage lumen from aperture 106. Anotherport, 116, part of attachment 112, can also be used with an inflationlumen or a drainage lumen. Connector 120 is part of an actuatingmechanism for extending and retracting tines 122. Connector 120 may beattached to another portion of an actuating mechanism such as a turnableknob or a lever (not shown), etc., that can be moved or rotated toextend or retract tines 122. Other variations of these features of theillustrated attachment and proximal end will be understood by those ofskill, and may be used in combination with the features of the presentinvention.

Generally, a method of the invention can include a step of performing aradical prostatectomy by a known or future developed technique, such asby a retropubic technique, a laparoscopic technique, or a transperinealtechnique. These techniques leave a bladder neck and a urethral stumpfor re-attachment. Prior techniques may use sutures or other mechanismsor structures that are separate from a catheter to re-attach the severedtissue. The use of sutures or other such separate mechanisms orstructures is preferably not necessary and most preferably avoidedaccording to methods of the invention.

The distal end of the anastomosis device may optionally be partiallyinstalled during the prostatectomy procedure, e.g., up to the perinealfloor, or may be installed to that point afterward. Following removal ofthe prostate, the catheter body of the distal end of the device ispassed through the urethral stump and then through the bladder neck.From there, the technique can include inflating the balloon inside ofthe bladder, and using tissue approximating structure to place thesevered tissue surfaces of the urethral stump and the bladder neck intocontact for healing. A preferred step can also be to close the bladderneck to a desired size via a purse-string suture.

From this point, the steps and techniques used to actuate the tissueapproximating structure and place the severed urethral stump and bladderneck tissue into contact for healing, can depend on factors that includethe structure and actuating mechanisms associated with the particularanastomosis device that is used.

Common to all vesico-urethral techniques can preferably be to carefullyavoid damaging sensitive tissues near the bladder neck and urethralstump. Specifically, ureters are proximal to the bladder neck and shouldnot be contacted. Proximal to the urethral stump are sensitive nervesand a sphincter. Some of these tissue structures are generally regardedas being at the 5 o'clock and 7 o'clock positions of the bladder neckand the urethral stump. Advantageously, the devices and methods of theinvention can afford significant opportunity to identify the location ofthese tissues, and position and reposition the tissue approximatingstructures to avoid them. As an additional feature of the device,markings can be made along a length of the outer surface of the catheterbody, e.g., at the location of apertures from which elongate tissueapproximating structures extend. A surgeon can view these markings whenpositioning the catheter body relative to a urethral stump and bladderneck, to avoid potential damage to sensitive tissue locations. Also inpreferred embodiments, elongate tissue approximating structures such astines or needles can be constructed and located to facilitate avoidanceof sensitive tissues, such as by providing a set of three tines thatradiate from a cross section of a catheter body at approximately 120degree angles apart from each other.

Examples of steps to install tissue approximating structures can bedescribed by reference to the figures. Referring to FIGS. 2 and 2 a, anexample of steps for using the tissue approximating structure of theillustrated embodiment of the anastomosis device shown, can be asfollows. Following inflation of balloon 26 inside of bladder 34, thebladder is pulled against perineal wall 14 (see FIG. 2 a). Severedbladder neck surface 25 contacts severed urethral stump tissue 27, toallow healing with the device 20 installed. Optionally and preferably,another form of tissue approximating structure may be employed proximalto the perineal floor 14 to produce pressure from the perineal floor 14against the bladder neck 24 and balloon 26. The additional form oftissue approximating structure may be in the form of a second balloon,or one or more elongate structures extending from the catheter body 21,through apertures, from underneath or at the level of the perineal wall14. FIG. 7, for example, shows a second balloon 80, which appliespressure to perineal floor 14, from below.

As another example, referring to FIG. 4 a, following inflation ofballoon 48 inside of bladder 34, the bladder is pulled against perinealwall 14. Severed bladder neck surface 25 contacts severed urethral stumptissue 27. Prior to or after pulling the bladder 34 to contact theperineal wall 14, a distal approximating structure in the form of tines54 are extended from catheter body 40 and penetrate bladder tissue 34,carefully avoiding ureters (not shown) optionally by reviewing theposition of tines 54 and repositioning or re-inserting the tines asnecessary either by retraction of the tines or by adjusting the positionof the catheter body 40 relative to the bladder tissue 34. Tines 54 maypenetrate into or through bladder tissue 34, as desired. After pullingthe bladder to contact the perineal wall 14, proximal tissueapproximating structure in the form of tines 56 are extended fromcatheter body 40 to penetrate perineal wall 14. Again, sensitive tissueis carefully avoided with optionally review and re-positioning of tines.Severed bladder neck surface 25 contacts severed urethral stump tissue27, to hold the severed tissue surfaces together to allow healing, whilethe anastomosis remains installed. Upon completion of the healingprocess, tines 54 and 56 are retracted back into the catheter body 40,and the device can be removed.

As still another example, referring to FIG. 5 a, following inflation ofballoon 68 inside of bladder 34, the bladder is pulled against perinealwall 14. Severed bladder neck surface 25 contacts severed urethral stumptissue 27. Tissue approximating structure in the form of tines 62,proximal to the perineal floor 14 can be extended to penetrate into andthrough perineal floor 14, and then further penetrate into bladdertissue 34. Severed bladder neck surface 25 contacts severed urethralstump tissue 27, to allow healing, while the anastomosis remainsinstalled. Upon completion of the healing process, tines 62 areretracted back into the catheter body 64, by use of actuator 61, and thedevice can be removed.

FIG. 6 a shows steps of another embodiment of a method and device of theinvention. Following inflation of balloon 78 inside of bladder 34, thebladder 34 is pulled against perineal wall 14. Severed bladder necksurface 25 contacts severed urethral stump tissue 27. Tissueapproximating structure in the form of tines 72, proximal to bladdertissue 34 can be extended to penetrate into and through bladder tissue34, and then further penetrate into perineal floor 14. Severed bladderneck surface 25 contacts severed urethral stump tissue 27, to allowhealing, while the anastomosis remains installed. Upon completion of thehealing process, tines 72 are retracted back into the catheter body 74,and the device can be removed.

FIG. 9 shows still additional embodiments of inventive methods anddevices relating to a urethral anastomosis procedure below the perinealfloor. FIG. 9 illustrates device 90 having distal end 92 installedthrough perineal floor 14 and into bladder 34, through urethra 8 whichpasses through prostate 10. This procedure does not include removal ofthe prostate, but instead relates to severing and re-attaching urethra 8at a point below perineal wall 14, e.g., re-attaching severed urethraportions 8 a and 8 b. According to the illustration, three tines 94 canbe used to place surfaces of severed urethra portions 8 a and 8 btogether, and hold them together for healing (see FIG. 9 a).Specifically, tines 94, total six tines, three as a distal set of tinespointed approximately away from the distal end of the device and threeas a proximal set of tines pointed approximately toward the distal endof the device. Each set, the distal set and the proximal set, isindependently movable by actuating mechanisms 96 and 98 to retract orextend through apertures in catheter body 99. When installed, tines 94are located along the catheter body 99 at a location that allows eachset to contact a severed urethra tissue portion.

FIG. 9 a illustrates the extended distal and proximal sets of tines 94extending into opposing portions of severed urethra 8 and holding thesevered tissue portions 8 a and 8 b in contact for healing. The tinescontact and move the portions together for healing. The installed devicealso includes a balloon in bladder 34 and drainage means that functiontogether to cause urine to pool in the bladder and drain from thebladder. Thus, the illustrated device may be left installed, includingthe tissue approximating structure, during the healing period. As willbe appreciated, other embodiments of the device may also be used in anend-to-end anastomosis procedure, such as other embodiments illustratedherein, including devices that include a single set of tines similar tothe tines of FIGS. 5 and 6.

FIGS. 9 b and 9 c are close-up illustrations of the tissue approximatingstructures of FIGS. 9 and 9 a, respectively, for clarity. As isillustrated in close-up FIGS. 9 b and 9 c, tines 94 can be extended fromcatheter body 99 to penetrate into and optionally (although perhaps notpreferably) through urethral tissue 8. The opposing severed urethraltissues are brought together (optionally with the assistance of theopposing tines) and are held together as shown in FIG. 9 c preferablyfor a time sufficient to cause healing together of the severed tissueswhile the anastomosis device is installed and functions to drain urinefrom the bladder.

An anastomosis device as described herein can remain installed in thepatient during the time required for healing of the two tissue surfacestogether, during which time the balloon remains inflated to preventurine from passing through the bladder neck. The healing period can beconsidered the time period taken for severed tissue to achieve a watertight anastomosis. The healing period can depend on many factors such asthe type of operation and the patient, and can take, e.g., from possiblyas little as one or two days, up to possibly two months, with periods offrom two to four weeks being sometimes typical.

While the device is installed, urine accumulates and pools inside of thebladder and can be drained from the bladder, preferably through drainageapertures and a drainage lumen within the anastomosis device, flowing tothe proximal end of the device for collection. Such preferredembodiments of the inventive devices and methods offers the advantage ofproviding a single anastomosis device that functions to allow thesevered tissue surfaces to heal together by use of the tissueapproximating structure, without sutures, while at the same timeproviding a draining mechanism. The advantage of not requiring suturesfor holding the severed tissues together or for healing can offer costsavings and eliminate complications by significantly reducing proceduretime, thus reducing costs, and also reducing the length of time apatient is anesthetized. Sutures do not have to be removed, but instead,the tissue approximating structures of the anastomosis device can beretracted or deflated, and the device can be removed after healing.

Following is one series of more detailed exemplary steps usefulaccording to the methods of the invention, for using the inventiveanastomosis device to perform a prostatectomy.

-   -   1. Perform a radical prostatectomy by any method such as        retropubic, laparoscopic, or transperineal, until prior to the        vesico-urethral anastomosis. The following description is in the        context of a retropubic radical prostatectomy, and with        reference to an embodiment of the inventive device as        illustrated at FIGS. 4 and 4 a.    -   2. Close the bladder neck to the desired size via a purse-string        suture.    -   3. The AD can be inserted into the bladder prior to the suturing        to help determine the desired size or the bladder can be sutured        independently.    -   4. Insert the AD through the meatus until it exits the urethral        stump in the open abdomen.    -   5. Pull the AD until enough length has been exposed to reach the        bladder.    -   6. Insert the AD into the bladder and inflate the balloon.    -   7. Extend the top (distal) tines of the AD and visually ensure        that the tines do not penetrate the ureters of the bladder. This        can be facilitated by extending and retracting the tines and        seeing the “bump” form on the exterior wall of the bladder. The        AD may also have visual markers on the external wall of the AD        proximal to the top tines to mark the location of the tines.    -   8. The bladder can then be lowered to the perineal floor by        releasing the traction on the bladder and physically moving it        down by hand while lightly maintaining tension on the AD.    -   9. Once the bladder has been drawn to contact the urethral        stump, a light tension can be placed on the AD while the        proximal tines are extended into the perineal floor.    -   10. The bladder can then be filled using the drainage port on        the AD and the anastomosis site can be checked for leaks.    -   11. If a leak is experienced the AD can be repositioned until        the desired performance is reached.    -   12. The AD can remain in place for a time depending on the        healing needs of the individual patient.

The invention claimed is:
 1. An anastomosis device comprising a hollow,elongate, flexible catheter body having a proximal end and a distal end,the distal end comprising a catheter body wall, an inflatable balloon atthe distal end, a drainage aperture at the distal end, and elongatetissue approximating structure that can be extended and retracted fromthe catheter body wall at the distal end of the catheter body on aproximal side of the inflatable balloon, wherein the inflatable balloonis on a proximal side of the drainage aperture, and wherein the tissueapproximating structure comprises movable elongate structure selectedfrom a tine, a probe, a prod, and a needle.
 2. The device of claim 1wherein, when the device is installed in a body having a prostateremoved, with the balloon in a bladder, the tissue approximatingstructure is capable of contacting tissue selected from tissue of abladder, tissue of a perineal wall, urethral tissue, and combinations ofthese.
 3. The device of claim 1 wherein the tissue approximatingstructure can be extended and retracted from apertures in the catheterbody using an actuating mechanism that extends through a lumen along aportion of the length of the device to the proximal end.
 4. The deviceof claim 1, comprising an inflation lumen extending from the proximalend to the balloon, a drainage lumen extending from the drainageaperture at the distal end to a port at the proximal end, and whereinthe tissue approximating structure comprises distal tissue approximatingstructure comprising movable elongate tines positioned to extend throughapertures in the hollow catheter body on the proximal side of theballoon, and proximal tissue approximating structure comprising movableelongate tines positioned to extend through apertures in the hollowcatheter body on the proximal side of the distal tissue approximatingstructure.
 5. The device of claim 1 wherein the tissue approximatingstructure comprises multiple tines.
 6. The device of claim 1 wherein thetissue approximating structure comprises multiple opposing tines.
 7. Thedevice of claim 1 wherein tissue approximating structure can be extendedand retracted from the catheter body wall at a fixed location on thecatheter body, the fixed location being fixed relative to the distal endof the catheter body and relative to the proximal end of the catheterbody, and wherein the balloon can be extended and retracted from thecatheter body wall at a fixed location on the catheter body, the fixedlocation being fixed relative to the distal end of the catheter body andrelative to the proximal end of the catheter body.
 8. The device ofclaim 7 wherein the tissue approximating structure comprises multipletines.
 9. An anastomosis device comprising a hollow, elongate, flexiblecatheter body having a proximal end and a distal end, the distal endcomprising a catheter body wall, an inflatable balloon at the distalend, a drainage aperture at the distal end, and elongate tissueapproximating structure that can be extended and retracted from thecatheter body wall at the distal end of the catheter body on a proximalside of the inflatable balloon, an inflation lumen extending from theproximal end to the balloon, a drainage lumen extending from thedrainage aperture at the distal end to a port at the proximal end, andmovable elongate tissue approximating structure positioned to extendthrough apertures in the hollow catheter body at the distal end, whereinthe inflatable balloon is on a proximal side of the drainage aperture.10. An anastomosis device comprising a hollow elongate flexible catheterbody having proximal end and a distal end, the distal end comprising acatheter body wall, an inflatable balloon at the distal end andinflation means to inflate the balloon, a drainage aperture and drainagemeans connected to the drainage aperture for draining urine from abladder, and elongate tissue approximating means on the proximal side ofthe balloon for holding severed tissue in contact for healing whereinthe inflatable balloon is on a proximal side of the drainage apertureand the tissue approximating means can be extended and retracted fromthe catheter body wall at a location along the distal end of thecatheter body, and wherein the tissue approximating means comprises amovable tine.
 11. The device of claim 10 further comprising actuatingmeans for actuating the tissue approximating means, the actuating meansconnected to the tissue approximating means and extending from thetissue approximating means to the proximal end.
 12. The device of claim10 wherein the tissue approximating structure is selected from the groupconsisting of an inflatable balloon, a movable elongate structure, and acombination thereof.
 13. The device of claim 10 wherein, with the devicepositioned to place the at least a portion of the catheter body insidethe urethra and the inflated balloon in the bladder, the tissueapproximating means can be extended to contact tissue selected from thegroup consisting of bladder tissue, urethral tissue, urethral stumptissue, and perineal wall tissue.
 14. The device of claim 10 whereintissue approximating means can be extended and retracted from thecatheter body wall at a fixed location along the distal end of thecatheter body, the fixed location being fixed relative to the distal endof the catheter body and relative to the proximal end of the catheterbody.
 15. The device of claim 14 wherein the tissue approximating meanscomprises multiple tines.
 16. An anastomosis device comprising a hollow,elongate, flexible catheter body having a proximal end and a distal end,the distal end comprising a catheter body wall, a drainage aperture atthe distal end, and tissue approximating structure at the distal end ofthe catheter body, the tissue approximating structure comprising firsttissue approximating structure and second tissue approximatingstructure, the first and second tissue approximating structure locatedon a proximal side of the drainage aperture, wherein each of the firstand second tissue approximating structure can be extended and retractedfrom the catheter body wall, and the second tissue approximatingstructure comprises elongate structure wherein, when the device ispositioned to place a distal portion of the catheter body inside theurethra, the first tissue approximating structure can be located tocontact tissue of the bladder and the second tissue approximatingstructure is located to contact tissue selected from tissue of abladder, tissue of a perineal wall, urethral stump tissue, tissue insidea urethra, and combinations of these, and wherein the second tissueapproximating structure is located on a proximal side of the firsttissue approximating structure, and the second tissue approximatingstructure comprises movable elongate structure selected from a tine, aprobe, a prod, and a needle.
 17. The device of claim 16 wherein thefirst tissue approximating structure is selected from the groupconsisting of a balloon and a balloon-like structure.
 18. The device ofclaim 17 wherein the first tissue approximating structure, when placedinside of the bladder, is capable of expanding within the bladder toprevent urine from passing through the bladder neck and urethra to ananastomosis site.
 19. The device of claim 16 wherein the second tissueapproximating structure comprises multiple opposing tines.
 20. Ananastomosis device comprising a hollow, elongate, flexible catheter bodyhaving a proximal end and a distal end, the distal end comprising acatheter body wall, a drainage aperture at the distal end, an inflatableballoon at the distal end on a proximal side of the drainage aperture,tissue approximating structure that can be extended through apertures inthe catheter body wall, at the distal end of the catheter body on aproximal side of the inflatable balloon, the tissue approximatingstructure comprising movable elongate structure selected from a tine, aprobe, a prod, and a needle.
 21. The device of claim 20 wherein thetissue approximating structure can be extended and retracted through theapertures in the catheter body using an actuating mechanism that extendsthrough a lumen along a portion of the length of the device to theproximal end.
 22. The device of claim 20 comprising distal tissueapproximating structure comprising movable elongate tines positioned toextend through apertures in the hollow catheter body on the proximalside of the balloon, and proximal tissue approximating structurecomprising movable elongate tines positioned to extend through aperturesin the hollow catheter body on the proximal side of the distal tissueapproximating structure, wherein the distal tissue approximatingstructure can be extended and retracted through the apertures in thecatheter body using an actuating mechanism that extends through a lumenalong a portion of the length of the device to the proximal end, andwherein the proximal tissue approximating structure can be extended andretracted through the apertures in the catheter body using an actuatingmechanism that extends through a lumen along a portion of the length ofthe device to the proximal end.
 23. An anastomosis device comprising ahollow, elongate, flexible catheter body having a proximal end and adistal end, the distal end comprising a catheter body wall, aninflatable balloon at the distal end, a drainage aperture at the distalend, and elongate tissue approximating structure that can be extendedand retracted from the catheter body wall at the distal end of thecatheter body on a proximal side of the inflatable balloon, wherein theinflatable balloon is on a proximal side of the drainage aperture, andwherein the tissue approximating structure comprises distal tissueapproximating structure comprising multiple tines, and proximal tissueapproximating structure comprising multiple tines that oppose themultiple tines of the distal tissue approximating structure, wherein thedistal tissue approximating structure can be extended and retracted fromthe catheter body wall at a fixed location on the catheter body, thefixed location being fixed relative to the distal end of the catheterbody and relative to the proximal end of the catheter body, and theproximal tissue approximating structure can be extended and retractedfrom the catheter body wall at a fixed location on the catheter body,the fixed location being fixed relative to the distal end of thecatheter body and relative to the proximal end of the catheter body. 24.The device of claim 23 wherein the position of the balloon on thecatheter body is fixed relative to the distal end of the catheter bodyand relative to the proximal end of the catheter body.
 25. Ananastomosis device comprising a hollow elongate flexible catheter bodyhaving a proximal end and a distal end, the distal end comprising acatheter body wall, an inflatable balloon at the distal end andinflation means to inflate the balloon, a drainage aperture and drainagemeans connected to the drainage aperture for draining urine from abladder, and elongate tissue approximating means on the proximal side ofthe balloon for holding severed tissue in contact for healing whereinthe inflatable balloon is on a proximal side of the drainage apertureand the tissue approximating means can be extended and retracted fromthe catheter body wall at a location along the distal end of thecatheter body, wherein tissue approximating means comprises distaltissue approximating means comprising multiple tines, and proximaltissue approximating means comprising multiple tines that oppose themultiple tines of the distal tissue approximating means, wherein thedistal tissue approximating structure can be extended and retracted fromthe catheter body wall at a fixed location on the catheter body, thefixed location being fixed relative to the distal end of the catheterbody and relative to the proximal end of the catheter body, and theproximal tissue approximating structure can be extended and retractedfrom the catheter body wall at a fixed location on the catheter body,the fixed location being fixed relative to the distal end of thecatheter body and relative to the proximal end of the catheter body. 26.The device of claim 25 wherein the position of the balloon on thecatheter body is fixed relative to the distal end of the catheter bodyand relative to the proximal end of the catheter body.
 27. Ananastomosis device comprising a hollow, elongate, flexible catheter bodyhaving a proximal end and a distal end, the distal end comprising acatheter body wall, a drainage aperture at the distal end, and tissueapproximating structure at the distal end of the catheter body, thetissue approximating structure comprising first tissue approximatingstructure and second tissue approximating structure, the first andsecond tissue approximating structure located on a proximal side of thedrainage aperture, wherein each of the first and second tissueapproximating structure can be extended and retracted from the catheterbody wall, and the second tissue approximating structure compriseselongate structure, wherein the first approximating structure can beextended and retracted from the catheter body wall at a fixed locationon the catheter body, the fixed location being fixed relative to thedistal end of the catheter body and relative to the proximal end of thecatheter body, and the second tissue approximating structure can beextended and retracted from the catheter body wall at a fixed locationon the catheter body, the fixed location being fixed relative to thedistal end of the catheter body and relative to the proximal end of thecatheter body.
 28. The device of claim 27 wherein the first tissueapproximating structure comprises an inflatable balloon and the secondtissue approximating structure comprises multiple tines.